Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
Public ClinicalTrials.gov record NCT04604652. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Open Label, Proof of Concept Study of HTD1801 (BUDCA) in Adult Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to Standard Therapy - PRONTO-PBC
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy. Inadequate response is defined as persistently elevated serum alkaline phosphatase at greater than or equal to1.5 times the upper limits of normal for the testing lab in spite of having been on adequate doses of standard therapy with UDCA (ursodeoxycholic acid) at 13-15 mg/kg for at least 6 months.
Study identification
- NCT ID
- NCT04604652
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 27, 2021 (Actual)
- Primary completion
- May 31, 2022 (Actual)
- Completion
- May 31, 2022 (Actual)
- Last update posted
- Aug 25, 2026
2021 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Miami Schiff Center for Liver Disease | Miami | Florida | 33136 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Henry Ford Health Services | Detroit | Michigan | 48202 | — |
| St. Louis University | St Louis | Missouri | 63104 | — |
| Northshore University Hospital | Manhasset | New York | 11030 | — |
| University GI | Providence | Rhode Island | 02905 | — |
| Baylor Research Institute | Dallas | Texas | 75246 | — |
| The Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Liver Institute of Virginia | Newport News | Virginia | 23602 | — |
| Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | — |
| Liver Institute Northwest | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04604652, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04604652 live on ClinicalTrials.gov.